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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02091817
Other study ID # sor010712ctil
Secondary ID ISF, 384/10
Status Suspended
Phase Phase 0
First received January 26, 2014
Last updated July 1, 2015
Start date November 2013
Est. completion date December 2017

Study information

Verified date July 2015
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether oxytocin affect face perception


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- normal or corrected to normal vision

Exclusion Criteria:

- minors

- pregnancy (according to a pregnancy test taken by subjects prior to participation)

- a history of asthma or nasal polyps

- cardiac disorders

- hyponatremia

- acute or chronic renal insufficiency

- liver cirrhosis

- neurological disease

- other chronic disease

- dementia, or lack of judgment

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
Intervention will be examined on control group, and on experimental group as well.
Placebo
Placebo will be given to control group and experimental group as well.

Locations

Country Name City State
Israel Soroka medical center Beer Sheva

Sponsors (2)

Lead Sponsor Collaborator
Soroka University Medical Center Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Avidan G, Behrmann M. Functional MRI reveals compromised neural integrity of the face processing network in congenital prosopagnosia. Curr Biol. 2009 Jul 14;19(13):1146-50. doi: 10.1016/j.cub.2009.04.060. Epub 2009 May 28. — View Citation

Avidan G, Behrmann M. Implicit familiarity processing in congenital prosopagnosia. J Neuropsychol. 2008 Mar;2(Pt 1):141-64. — View Citation

Avidan G, Hasson U, Malach R, Behrmann M. Detailed exploration of face-related processing in congenital prosopagnosia: 2. Functional neuroimaging findings. J Cogn Neurosci. 2005 Jul;17(7):1150-67. — View Citation

Avidan G, Tanzer M, Hadj-Bouziane F, Liu N, Ungerleider LG, Behrmann M. Selective dissociation between core and extended regions of the face processing network in congenital prosopagnosia. Cereb Cortex. 2014 Jun;24(6):1565-78. doi: 10.1093/cercor/bht007. Epub 2013 Jan 31. — View Citation

Behrmann M, Avidan G, Marotta JJ, Kimchi R. Detailed exploration of face-related processing in congenital prosopagnosia: 1. Behavioral findings. J Cogn Neurosci. 2005 Jul;17(7):1130-49. — View Citation

Hasson U, Avidan G, Deouell LY, Bentin S, Malach R. Face-selective activation in a congenital prosopagnosic subject. J Cogn Neurosci. 2003 Apr 1;15(3):419-31. — View Citation

MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Memory performance At the day participants will administer the substance, they will view a set of faces, of which they will be tested about 24 hours later. The measures that will be tested are %accuracy and %dwell time of eye movements towards each region in the faces the participants saw. Day 2 (24 hours after encoding) No
Secondary Mood measurement Participants will fill a PANAS mood questionnaire in order to monitor the effects of mood and fatigue of oxytocin/placebo. We will use ANOVA on the total score of the test in order to verify that differences in performance are not due to change in mood or fatigue after substance uptake. Day 1 (after oxytocin/placebo uptake) No
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